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French health regulator reviews use of Avastin to treat AMD

7 November 2014

College Statement

The RCOphth notes with interest the move by the French health regulator, French National Agency for Medicines and Health Products Safety (ANSM), in asking Roche to provide information on the safety and efficiency of the off-label use of bevacizumab (Avastin) to treat wet age-related macular degeneration (AMD).

Ranibizumab (Lucentis), which is licensed as an anti VEGf treatment for AMD is currently the most expensive single drug treatment for the NHS – this includes drugs for all conditions including cancer and heart disease.

The information provided by Roche, which has three months to respond, will be combined with ANSM’s own research and examined early next year by a risk-benefit committee, with a recommendation expected to be made public in the first half of 2015.

ANSM asked the pharmaceutical company for any available data on the safety and efficacy of Avastin in the treatment of AMD. The regulator also requested that Roche clarify how it plans to monitor patients treated with Avastin for off-label uses. In the UK, Avastin is produced by Novartis.

The RCOphth asks the NHS to instruct NICE and the Medicines and Healthcare Products Regulatory Agency (MHRA) to consider similar issues about the role of Avastin in the treatment of AMD.

In a previous statement in 2011, RCOphth had said that:

‘Ophthalmologists should have the discretion to use Avastin rather than Lucentis for the treatment of AMD if it is in the patient’s best interest to do so and provided the patient gives informed consent. This may occur, for example, when an ophthalmologist wishes to use an anti-VEGF agent earlier than specified in the NICE guidelines or when the patient has failed to respond to Lucentis.’

Pharmatimes Digital reported in 2013 that a saving of £84million could be made to the NHS by switching to Avastin.